Text Messaging for HIV Prevention

Recruiting at 1 trial location

Overseen By Gabriel Federo Hungria, MD, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: HIV infection, Other HIV study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

266 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on text messaging for HIV prevention, so it's unlikely that your current medications will be affected.

What data supports the effectiveness of the treatment TM HIV, Text Message-Based HIV Prevention Intervention?

Research shows that text messaging interventions can improve health outcomes for people living with HIV by promoting adherence to antiretroviral therapy (ART), which is crucial for maintaining health and reducing HIV transmission. Text messages have been effective in supporting behavior change and medication adherence, making them a promising tool for HIV prevention. ^{1 2 3 4 5}

Is text messaging for HIV prevention safe for humans?

Text messaging interventions for HIV prevention have been used safely in various studies, showing high acceptance and engagement among participants without any reported safety concerns. ^{2 3 6 7 8}

How is the Text Messaging Intervention for HIV prevention different from other treatments?

The Text Messaging Intervention for HIV prevention is unique because it uses mobile phone text messages to increase awareness and encourage testing, targeting specific high-risk groups like construction workers and men who have sex with men. Unlike traditional treatments, this approach focuses on behavior change and engagement through digital communication, making it accessible and adaptable during situations like the COVID-19 pandemic. ^{1 2 6 7 9}

What is the purpose of this trial?

This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers. The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.

Research Team

Michelle Henshaw, DDS, MPH

Principal Investigator

Boston University Goldman School of Dental Medicine

Eligibility Criteria

This trial is for English or Spanish-speaking dental patients at certain health centers who have HIV risk factors like multiple sex partners, but are not HIV-positive. They must be able to give informed consent and commit to the study's duration.

Inclusion Criteria

Give informed consent and document consent via a signed and dated informed consent form in REDCap

I can read in English or Spanish.

Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria

I am a woman who has sex exclusively with women.

Has not used any type of text messaging at least once in the past month

Does not have a mobile phone or other device which can receive text messages from Agile Health

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Pilot

A feasibility pilot to test the text message delivery and study procedures

2 months

3 visits (self-report surveys at baseline, 1 month, and 2 months)

Treatment

Participants receive text messages regarding HIV prevention or overall wellness and complete self-report surveys

6 months

4 visits (self-report surveys at baseline, 3 months, 6 months, and 12 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (self-report surveys at 6 months and 12 months)

Treatment Details

Interventions

• TM HIV
• TM HL

Trial Overview The study tests a text message program over three years. Participants will receive texts about either HIV prevention or general wellness. The goal is to see if these messages can help reduce the risk of getting HIV.

Participant Groups

Group I: HIV text messages (TM HIV) Experimental Treatment 1 Intervention

Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing.

Group II: TM HL Active Control 1 Intervention

Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing..

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Findings from Research

Text messaging interventions have been shown to effectively improve adherence to antiretroviral therapy and increase appointment attendance among people living with HIV, based on a systematic review of nine high-quality reviews involving 37 studies across 19 countries.

There are significant knowledge gaps regarding long-term outcomes and patient satisfaction with text messaging interventions, indicating a need for further research to fully understand their impact and potential in managing other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. Mbuagbaw, L., Mursleen, S., Lytvyn, L., et al.[2022]

A review of 51 studies highlighted the importance of developing SMS content for mHealth initiatives aimed at supporting HIV/AIDS treatment adherence, emphasizing the need for formative research and grounding messages in behavior change theory.

Best practices for creating effective SMS messages include consulting with experts and using established behavior change frameworks to enhance the effectiveness of mobile health interventions in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. Kerrigan, A., Kaonga, NN., Tang, AM., et al.[2023]

Text messaging interventions significantly improve adherence to antiretroviral therapy in people living with HIV, with an odds ratio of 1.39, indicating a notable increase compared to control conditions.

Interventions that are less frequent, allow for two-way communication, include personalized messages, and align with participants' medication schedules are particularly effective, also leading to improved viral load and CD4+ counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. Finitsis, DJ., Pellowski, JA., Johnson, BT.[2022]

This study aims to analyze data from three randomized controlled trials involving text messaging interventions for improving adherence to antiretroviral therapy (ART) among people living with HIV, focusing on individual patient data from 2 Kenyan and 1 Cameroonian trial.

The meta-analysis will explore how factors like age, gender, education level, and duration on ART influence the effectiveness of text messaging, potentially identifying which patient groups benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials. Mbuagbaw, L., van der Kop, ML., Lester, RT., et al.[2022]

The study demonstrated that text message surveys are a feasible method for assessing HIV-related economic and sexual risk behaviors among economically disadvantaged African-American young adults, with a 65% response rate from participants.

Participants showed a high engagement level, answering an average of 12.6 out of 14 questions each week, indicating that text messaging can effectively gather important data on sensitive topics like sexual health and economic behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study. Jennings Mayo-Wilson, L., Glass, NE., Labrique, A., et al.[2021]

A mobile text messaging intervention for HIV prevention was successfully implemented among 464 employees in the construction industry, achieving a high message delivery rate of 91.6% and 100% read rate, indicating strong engagement.

The intervention led to 21.6% of participants reporting they had taken an additional HIV test since the initial workplace testing, suggesting that SMS messaging can effectively promote HIV testing and awareness even during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test@Work Texts: Mobile Phone Messaging to Increase Awareness of HIV and HIV Testing in UK Construction Employees during the COVID-19 Pandemic. Middleton, M., Somerset, S., Evans, C., et al.[2020]

The Connect4Care (C4C) text messaging intervention did not significantly improve virologic suppression rates among HIV patients after 12 months, with 48.8% in the intervention group compared to 45.8% in the control group.

However, newly diagnosed patients showed higher suppression rates (78.3% vs 45.3%), and the study suggests that patient engagement through responses to text messages may be an important factor in achieving better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Christopoulos, KA., Riley, ED., Carrico, AW., et al.[2022]

The SMS intervention for managing HIV Viral Load results in Zimbabwe was found to be acceptable to both patients and healthcare workers, improving adherence and management of results despite some implementation challenges.

While the intervention has the potential to reduce unnecessary clinic visits and enhance patient engagement in their HIV care, it requires clear communication and counseling to address concerns about message clarity and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. Venables, E., Ndlovu, Z., Munyaradzi, D., et al.[2020]

A survey of 5,378 men who have sex with men (MSM) found that 49% of mobile phone owners were willing to receive text messages for an HIV-prevention study, indicating moderate interest in this intervention.

Willingness to receive text messages varied by demographics, with Black and Hispanic MSM showing more interest than White non-Hispanic MSM, and younger participants (under 22) being more receptive than older participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are MSM willing to SMS for HIV prevention? Khosropour, CM., Lake, JG., Sullivan, PS.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Test@Work Texts: Mobile Phone Messaging to Increase Awareness of HIV and HIV Testing in UK Construction Employees during the COVID-19 Pandemic. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Are MSM willing to SMS for HIV prevention? [2022]